The present disclosure relates to instruments for accessing intraosseous regions of bone for conveying thereto agents such as bone graft substitutes. For example, disclosed and described are instruments, systems, kits, and methods for accessing intraosseous regions of bone (bone marrow containing regions of bone), including, for example, in accessing intraosseous spaces at, near, or within a bone marrow lesion (“BML”). Thus, one aspect of this invention relates to treating BMLs by using the disclosed instruments and methods to access regions of bone pertinent to a BML to be treated and providing a conveyance for a treatment substance, such as a bone graft substitute (“BGS”), to be injected into a region of bone at, near, or within by a BML. In a non-limiting example, embodiments of the devices, systems, kits, and methods may be used for bone augmentation in the knee.
More particularly, for example, the instruments, systems, kits, and methods disclosed may include an elongated tubular member (a cannula, a cannula needle, or a cannulated probe) having distal and proximal ends, an elongated wire (a stylet) having distal and proximal ends, the distal end which may be sharpened and/or pointed, the elongated wire slidably disposable within at least one lumen of the cannula, a drill stop having distal and proximal ends and attachable to the stylet, the drill stop also having drill stop extensions extending distally from the distal end and coaxially with the axis of the lumen and stylet, a luer lock (or “luer-type lock,” used interchangeably herein with the term “luer lock” when referring to the invention disclosed herein) having distal and proximal ends and a body through which runs a channel between the proximal and distal ends, the luer-type lock attachable to the proximal end of the cannula, the luer lock body having luer lock (luer-type lock) slots extending distally into the luer lock from the proximal end of the luer lock and coaxially with the axis of the cannula. Further, the drill stop extensions are slidably but reversibly engageable within the luer-type lock slots when the distal end of the drill stop, from which the drill stop extensions extend, is proximate proximal end of the luer-type lock, in which the luer lock slots are located. Because the drill stop, and thus the drill stop extensions, are attachable to the stylet, and the luer lock and the luer lock slots are attachable to the cannula, when attached, rotation about the axis of the stylet only causes concurrent or synchronized rotation about the cannula (and vice versa).
The luer-type lock may further have luer lock projections (luer-type lock projections) that extend perpendicularly (or radially about the width of the projections) from the proximal end of the luer lock.
The coupling of the cannula and the stylet (via reversibly insertion of the drill stop extensions within the luer-type lock slots) may be further reversibly coupled by a luer-type lock cap (cap) having proximal and distal ends where the cap is slidably engageable over the proximal end of the stylet through a stylet opening in the proximal end of the cap where the internal diameter of the stylet opening is greater than the exterior diameter of the stylet, yet is less than the external diameter of the drill stop and the external diameter of at least a region proximate the proximal end of the luer lock containing the luer lock projections.
The distal end of the cap has a distal opening to and an internal threaded chamber of the cap. The internal diameters of the distal opening and internal threaded chamber of the cap are greater than the external diameters of the drill stop and at least a region proximate the proximal end of the luer lock containing the luer lock projections. Therefore, when the distal end of the drill stop is proximate the proximal end of the luer-type lock, the cap receives and retains the entire drill stop and at least a region proximate the proximal end of the luer-type lock containing the luer lock projections. The internal threads of the luer-type lock cap are then threadably engageable over the luer lock projections and the cap reversibly tightened against the proximal end of the luer lock, including reversibly coupling the drill stop on the stylet with the luer lock on the cannula by reversibly holding together the drill stop extensions within the luer lock slots.
The assembled devices, systems, and kits are further reversibly or permanently connectable with drill, such as a manual drill, a power drill (e.g., a power surgical drill), and a wire drill. The drills may drill in one direction or be reversible drills. In any event, the drill is capable of engaging the proximal end or end region of the stylet (elongated wire) of the device and of thereby rotating the entire assembled tool, at set or variable speeds and/or directions controlled by an operator, a computer algorithm, or both. A drill may be connected to the device, such as to the proximal end of the stylet, throughout the assembly, use, and disassembly of the device or at any times therein, provided it is coupled to the device when drilling is needed.
In embodiments where a drill connects to and rotates the elongated wire (stylet) portion of the device, the elongated wire may be reversibly coupled to the cannula, as discussed above and in detail below, rotation about the axis of the stylet causes concurrent or synchronized rotation about the axis of the cannula. Such concurrent or synchronized rotation assists in inserting both the cannula and stylet into a desired location within an intraosseous space of a bone; it also assists in drilling into the surface of bone. For example, in some embodiments, the distal (drilling) end of the cannula may have teeth, and/or the tip of the stylet may extend beyond the end of the cannula (as discussed below) and be pointed and/or sharpened, such that pointed and/or sharpened tip of the stylet makes the first entry point of the device into bone (in effect establishing an initial “pilot hole” in the surface of the bone from which drilling may begin). Without limitation, or bound by theory, this process of initiating drilling into bone may, among other things, help hold and stabilize the device at an initial desired location on the surface of a bone to be drilled by the tip of the stylet forming a type of “pilot hole,” thereby helping to alleviate problems known in the art such as sliding and skipping of a bone access device on a bone's surface (which may be dense and/or slippery) when trying to initiate drilling at a desired location on the bone. These features further assist entry of the device into the intraosseous region of a bone when the device is rotated by a drill.
In embodiments, after the cannula—stylet coupled device has been advanced by drilling to a desired location in an intraosseous region, the cannula is kept in place in order to act as a conduit for injection of a desired substance into the accessed bone space (e.g., for the injection of bone graft substitute into a bone marrow lesion accessed by the device). While the cannula remains in place, the cap is unthreaded from the projections of the luer lock, reversibly removing this aspect of coupling the stylet and cannula. The stylet is then reversibly removed from the cannula, and therefore simultaneously the extensions of the drill slot are reversibly disengaged from within the slots of the luer lock.
When the elongated wire has been fully removed from the cannula, an injection device, such as by non-limiting example a syringe, may be reversibly attached to the luer lock at the proximal end of the cannula and a desired substance (such as BGS) may be injected into an accessed intraosseous space, such as one having a BML. Following injection, the cannula may be removed from the bone, for example, by manual force (with or without the injection device (e.g., a syringe) attached to the luer lock), such as by a surgeon removing the cannula by manually pulling and/or twisting.
As discussed below, in certain embodiments of the invention, after injecting a desired amount of treatment substance (e.g., BGS) into a BML, the lumen may be removed from the bone with, for example, the assistance of a drill. In these embodiments, the injection device is removed from the distal end of the cannula following use of the injection device, and the stylet is then reinserted (or inserted if a new or different stylet is used from the original elongated wire) into the cannula (where the reinserted stylet can include the same cannula first used in drilling, which may have the same or opposite locations of sharpened ends relative the ends of the cannula, or, for example, may be a dual blunt end stylet). Next, the device is fully reassembled including, for example, reassembling the luer lock—drill stop coupling and reattaching the cap to the luer-lock. In such a reassembled device (or any similar reassembly that reconnects a stylet with the cannula) the proximal end and/or region of the stylet may be used to assist in removing the device from the bone. For example, a manual or power surgical drill may be attached to the proximal end and/or region of the stylet and the drill used to rotate the stylet about its axis causing concurrent or synchronized rotation about the cannula which assists in backing the device out of the bone.
In other embodiments of the invention, a device that is capable of withdrawing (e.g., applying a suction force, e.g., a syringe, a collection device, a vacuum device, and the like) is also reversibly attachable to the luer lock at the proximal region of the cannula end after the stylet has been withdrawn. In embodiments, when a withdrawing device is used, it is coupled to the luer lock at the proximal region of the cannula end and used to withdraw a sample from the accessed intraosseous space (such as a BML). In embodiments where a withdrawing device is used, it is reversibly attached to the luer lock and the proximal end of the lumen (generally but not necessarily after the stylet has been removed) and used to apply a suction force to an accessed region and capture any sample therefrom before being disengaged from the luer lock and cannula. In such embodiments, following disengagement of the withdrawal device from the luer lock and cannula, an injection device is then reversibly attached to the luer lock at the proximal region of the cannula end of the cannula and a desired substance (such as BGS) may be injected into an accessed intraosseous space, such as one having a BML. However, it is within the scope of this invention to use the described devices only to withdraw a sample from an intraosseous space. In such cases, for example, the drilling into the intraosseous space, uncoupling the stylet (and removing it from) the cannula (and disengaging related components) are the same as for other uses herein, the difference being that after disengaging the withdrawal device the cannula would be removed without an injection step (or injection device) (such as by reassembling the device including reinserting a stylet and using rotation of the stylet to back the cannula out of the bone).
As discussed above, the device may also be reassembled, for example, by removing the substance injection device (e.g. syringe) from the proximal end of the luer lock, and reinserting the stylet into a lumen of the cannula, reinserting the drill stop extensions of the drill stop (attached to the stylet) into the luer lock slots (the luer lock slots part of the luer lock which is attached to the cannula) and assuring stable recoupling the stylet and cannula by rethreading the luer lock cap over the drill stop and over at least a region proximate the proximal end of the luer lock containing the luer lock projections, wherein inner threads of the cap threadably engage over the luer lock projections. Once reassembled (recoupled) the drill may be reattached to or near the proximal end of the stylet (if it was removed during any preceding aspect, which is not necessarily required), and the drill activated in the opposite direction from drilling in order to back the cannula and stylet out of the accessed bone.
There are currently available manual devices that are able to couple a stylet and a cannulated needle and access intraosseous sites. These devices, such as Jamshidi® or T-handle needles, also allow for the ability to couple a syringe to the device to deliver substances, including bone marrow, bone marrow substitutes, and bone graft substitutes, into an accessed intraosseous space.
However, the BML access instruments, systems, and kits known in the art are solely to manual drive for twisting the instrument on insertion and removal—not to power drive. Manual drives of intraosseous region (e.g., BML) access and treatment instruments complicate accessing a desired intraosseous region for several reasons. For non-limiting examples, the outside of bone is dense, hard, and slippery, while breaching the outside of bone at a precise location is important in order to access a desired intraosseous location with precision. A medical professional must apply a sufficient amount of pressure and rotation to an access device to both begin insertion accurately at the desired location on the outside surface of the bone, and to reach a desired location within a bone; too much pressure may damage the bone and lack of sufficient pressure and speed of rotation may cause the instrument to slip (skid, or jump) from its desired insertion location on the surface of the bone. Additionally, lack of sufficient pressure and speed of rotation may adversely affect a surgeon's control over the course of a tunnel within a bone, making it, for example, possible to stop short of, overshoot, or otherwise miss accessing desired BML locations, and even to drill completely through a bone, such as back out of an opposing side of a bone such as a femur. Lack of powered drilling may also make the insertion, and removal, of bone access devices more physically demanding, placing additional burden on a surgeon, and raising the possibility of damaging, for example, a surgeon's hand and/or wrist. Easing the difficulties associated with manually inserting tools may also allow surgeons so more readily focus on the precision of the placement, advancement and final position of the tool.